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U.S. Government Expands Population Eligible to Receive Bavarian Nordic's Smallpox Vaccine in an Emergency

Jul 17, 2012 3:18pm

U.S. Government Expands Population Eligible to Receive Bavarian Nordic's Smallpox Vaccine in an Emergency

Wed Jul 11, 2012 2:01am EDTPeople with Atopic Dermatitis and HIV Now Eligible to Receive IMVAMUNER in an Emergency

KVISTGAARD, Denmark, July 11, 2012 - Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. government has expanded the population that is eligible to receive its attenuated smallpox vaccine, IMVAMUNER , during an emergency. In the event of a public health emergency involving smallpox, the government may now authorize the use of IMVAMUNER to protect individuals of all ages with HIV infection or atopic dermatitis (AD). Children, pregnant women, and nursing mothers with HIV or AD are eligible to receive IMVAMUNER , despite limited clinical data in these specific populations. Previously, only certain people with HIV were eligible.

The U.S. government currently stockpiles enough traditional smallpox vaccine to protect the entire American public in the event of a smallpox bioterrorism attack. However, these replicating smallpox vaccines may cause severe complications for people with compromised immune systems or AD. IMVAMUNER is being developed as an alternative for these individuals.

"Bavarian Nordic is pleased that our continuing development of IMVAMUNER supports the United States' goal of developing medical countermeasures for at-risk populations like children with atopic dermatitis," said Bavarian Nordic President and CEO Anders Hedegaard. "We are committed to ensuring the most vulnerable populations have access to medical countermeasures suited for their age and condition."

"The National Eczema Association applauds the U.S. government's efforts to develop and stockpile a smallpox vaccine that can be safely used by the millions of Americans living with atopic dermatitis," said President and CEO of the National Eczema Association Julie Block. "We are pleased that the government has prioritized the unique needs of the individuals we represent and encourage the Department of Health and Human Services to ensure that in the event of an emergency all atopic dermatitis sufferers have access to this new vaccine."

The Biomedical Advanced Research and Development Authority (BARDA) highlighted the need to protect these vulnerable populations in its 2010 Broad Agency Announcement for Medical Countermeasure Development, in which it noted the need for sufficient quantity of attenuated smallpox vaccine to protect 28 million people with atopic dermatitis, 10 million people with compromised immune systems, and their household contacts, totalling 66 million people.

To date, the government has ordered 20 million doses of IMVAMUNER to protect the 10 million people with immune deficiencies, in particular HIV. Bavarian Nordic expects to complete delivery of these vaccine doses by 2013. Bavarian Nordic is also working with BARDA to further improve IMVAMUNER by developing a freeze-dried version of the vaccine, which may have a longer shelf-life and simplified shipment and storage logistics.

"Bavarian Nordic will soon complete the manufacture of IMVAMUNER for the Strategic National Stockpile," said Paul Chaplin, Infectious Disease Division President. "With this significant increase of the eligible population we anticipate that this will lead to a long term business relation with HHS to ensure IMVAMUNER is available to protect all Americans with atopic dermatitis and HIV from smallpox."

Asger Aamund
Chairman of the Board

Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64

About atopic dermatitis
Atopic dermatitis is often referred to as atopic eczema or infantile eczema, which is a specific type of eczema that is chronic, relapsing and frequently associated with other type 1 allergic disorders such as asthma, food allergies and allergic rhinitis. People with AD tend to have a mild immune defect in their skin that can allow certain viruses such as vaccinia (the live virus used in conventional smallpox vaccines) to spread both over the skin and internally, which may cause severe complications. These potentially life threatening complications, include progressive vaccinia, generalized vaccinia, myo-/pericarditis and eczema vaccinatum.

IMVAMUNER smallpox vaccine and the immunocompromised population
Clinical trial data from over 3,400 people, including nearly 600 people with HIV and nearly 400 people with AD in 15 ongoing or completed studies indicate that IMVAMUNER has a favourable safety profile and is well tolerated, including in individuals who should not receive conventional smallpox vaccines. IMVAMUNER is the first new vaccine developed under the U.S. government's "Project BioShield" that protects vulnerable populations like those with HIV and AD from bioterrorism.

About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company's pipeline targets cancer and infectious diseases, and includes ten development programs. In oncology, the company's lead program is PROSTVACR , a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVACR has been tested in nearly 600 patients. In infectious diseases, the company's lead program is IMVAMUNER , a third-generation smallpox vaccine candidate that is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. For more information, visit www.bavarian-nordic.com

Forward-looking statements
This announcement includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.